Cleared Traditional

RLS 9100 RHINO-LARYNGEAL STROBOSCOPE

K921184 · Kay Elemetrics Corp. · Ear, Nose, Throat
May 1992
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K921184 is an FDA 510(k) clearance for the RLS 9100 RHINO-LARYNGEAL STROBOSCOPE, a Laryngostroboscope (Class I — General Controls, product code EQL), submitted by Kay Elemetrics Corp. (Pine Brook, US). The FDA issued a Cleared decision on May 28, 1992, 80 days after receiving the submission on March 9, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4750.

Submission Details

510(k) Number K921184 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1992
Decision Date May 28, 1992
Days to Decision 80 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EQL — Laryngostroboscope
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4750

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